National Institutes of Health (NIH)
U.S. Army Medical Research and Materiel Command (USAMRMC)

Components of Participating
Organizations

National Heart, Lung, and Blood Institute (NHLBI)
Office of Behavioral and Social Sciences Research (OBSSR)
Telemedicine and Advanced Technology Research Center (TATRC)
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)

Funding Opportunity Title

Virtual Reality Technologies for Research and Education in
Obesity and Diabetes (R01)

May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

July 6, 2011 - See Notice NOT-HL-11-152 Notice of Publication of FAQs.

The purpose of this Funding Opportunity Announcement (FOA)
is to encourage submission of hypothesis-testing research applications that
capitalize on the unique capabilities of Virtual Reality (VR) technologies to
visualize outcomes, teach, motivate, and to extend the health care and
learning environments, in order to foster to foster desirable eating,
physical activity, self-care, and other health-related behaviors necessary
for prevention and management of obesity and diabetes.

Of highest interest are well-designed multidisciplinary
projects drawing on expertise in VR technologies and biomedical behavioral
and pedagogical sciences. The overall goal is to develop the potential of VR
technologies as research tools for behavioral science-oriented studies in
diabetes and obesity, and as practical tools for clinical and public
health-level prevention and management of obesity and diabetes.

Key Dates

Posted Date

May 10, 2011

Open Date (Earliest Submission Date)

May 16, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The public health infrastructure is being overwhelmed by
problems related to over-eating and under-exercising, and it has become clear
that many, perhaps most, people have difficulty assimilating and implementing
information on optimal diet and physical activity. Furthermore, the emotional,
cognitive, and logistical complexities of diabetes management have resulted in
a situation where a large fraction of patients are in sub-optimal glycemic
control, leading to poor clinical outcomes and high expenses. Even if
individuals are willing to adhere to professional and public health guidance,
it is hard to navigate the emotional demands, environmental choices and
opportunity cost issues that present themselves at the point of decision. This
is the cause of failure for many approaches seeking to promote positive
behavioral changes, which is of particular concern for individuals with obesity
and diabetes.

Virtual Reality (VR) technologies might prove useful in bridging the gap
between information (healthy population guidance or therapeutic lifestyle
change guidance for obesity and diabetes) and sustainable behavior change. VR
technology allows users to interact with (rather than simply observe)
computer-simulated environments, typically with adapted flat-screen monitor
displays or stereoscopic goggles, but also sometimes with tactile (“haptic”) or
other sensory feedbacks including taste and smell. Online communities and
virtual worlds with avatars (animated characters representing oneself or
others) are increasingly a component of the everyday social world for many
people.

VR applications are currently in development and use for a
number of health- and medicine-related issues, notably rehabilitation medicine
(stroke, Parkinson’s disease, pain control in burn victims), behavioral
medicine (phobias, post-traumatic stress disorder, drug addiction, autism), and
surgery (technical training, robotics, remote site treatment). However, except
for small studies in clinical eating disorders (anorexia, binge eating), there
has been almost no development of the field in relation to common issues of
food intake, food choice and encouragement of physical activity among the
broader population.

VR technology could be used to complement motivational interviewing, assess
emotional states of readiness for behavioral change, and help patients to
grapple with their emotional reactions to food choices. The visual
presentations could assist patients in adjusting their distorted assessments of
portion sizes; correcting their unrealistic expectations of the rate of weight
loss; managing sensory experiences that occur as a result of behavior change,
such as hunger or satiety from altered consumption patterns, or delayed muscle
soreness from unaccustomed exercise; and enhancing their sense of self-efficacy
by giving them successful experiences in navigating virtual environments.

VR also might be suitable for addressing adherence barriers
in cardiovascular exercise rehabilitation (particularly for coronary artery
disease, heart failure, and peripheral arterial disease) such as perceived
exertion, anxiety, and capacity to walk to a prescribed duration and
intensity. Another clinical use of VR might be in the provision of
non-judgmental support for patients with various medical conditions through virtual
coaches, and it might be especially suitable for housebound or reclusive
individuals with social anxieties or mobility restrictions due to morbid
obesity or other medical conditions. VR could be used in the therapeutic
setting as a component of patient visits, to help guide and select educational
materials and strategies and timelines. It might be an especially suitable
modality for children, adolescents and young adults, who already are becoming
familiar with VR as an entertainment technology. VR could also be applicable
to individuals with low verbal or numerical literacy who may be more oriented
to pictorial (vs. written or abstract) information.

VR has some unique characteristics as a research tool. The
virtual environments can be designed to address specific hypotheses, and data
on the study participant’s response to the intervention can be collected in
high detail without additional intrusiveness. Phenomena that are amenable to
study, and also treatment, include cue responsiveness and extinction through
virtual exposure, a feature that has been used to advantage in treatment of
phobias and addictions. Visual presentations can be tailored to the user, along
with therapeutic guidance to modify affective reactions and choices, and can
prepare the user for future “real-world” encounters, thus making VR suitable
for role-playing and training. Performance feedback, an essential component of
learning and skill acquisition, can occur in real-time; thus VR can be used as
a teaching tool and also to study cognitive processing of information presented
in increasingly complex (‘hierarchical”) environments, a research approach that
often is not practical in “real world” settings. Also, the capability to
distribute identical virtual environments across multiple locations gives new
meaning to the concept of multi-site data collection.

For researchers, an advantage is that the VR approach can
simultaneously deliver an intervention and collect data on how it is utilized,
particularly with regard to the cognitive and emotional processes involved.
Study design and methodology challenges include: identification of appropriate
control groups and control conditions, and of characteristics of rigorous
efficacy and effectiveness studies of VR; exploration of ethical issues with
different types of studies such as direct comparison designs (Standard of Care [SOC]
vs. VR) and additive designs (SOC vs. SOC+VR); characterization of how participant
traits (such as age, literacy and numeracy level, motivation and other
cognitive and psychosocial traits), and previous gaming experience moderate
technology usability and study outcomes; development of well-defined metrics
for assessment of interventions and outcomes, including actual as well as
intended VR “dose;” development of VR research tools that could be used in
group or multi-site formats (e.g. classrooms); and development of methods for
mining data from existing health games for research purposes.

SELECTED
RESEARCH EXAMPLES:

There is a need for both developmental VR research leading
to new methods and technologies and marketable commercial products. There is
also the need for research that provides a venue for well-powered effectiveness
trials of the new interventions. Progress in the field will be enhanced
by multidisciplinary collaborations between the technology industry and
academia, and among researchers with diverse expertise in biomedical sciences
(such as endocrinology, nutrition, and exercise physiology), behavioral science
and pedagogical disciplines, and computer sciences including VR technologies.
There is a need to document and evaluate currently available off-the-shelf
programs. Projects will need to be clearly defined with regard to: research
questions, technical approach, VR platforms, target population (by age, health
condition, psychological status, education or literacy level, etc), and
research outcomes. Many projects can be usefully conducted taking advantage of
already existing tools, games, and software, although there is also a need to
develop unique technologies.

The Telemedicine and Advanced Technology Research Center (TATRC) has substantial in-house subject matter
expertise and experience in the application of information technologies,
virtual reality, augmented reality, and gaming technologies for healthcare. If
the applicant would like to have the research project considered for
supplemental funding from TATRC, a paragraph defining the military relevance
should be included as such. Note that NIH grants policies as described in the NIH Grants
Policy Statement will apply to all applications submitted and awards made
in response to this joint-agency FOA.

Applications should involve development, use or adaptation
of immersive or non-immersive VR environments. Those projects focusing only on
electronic means of research data collection (so-called “e-tools”), without VR
components, will not fit the research objectives of this FOA.

Potential areas for hypothesis-testing research, and for
exploratory, developmental or evaluation research, include (but are not limited
to):

Using VR to foster desirable eating, physical activity, and
other health-related behaviors:

Making smarter eating choices in various locations (such as home,
restaurants, school cafeteria).

Understanding the effects of chemical senses input (taste, smell)
in combination with VR modalities on learning and motivation processes related
to food intake and food choice.

Exploring how social context affects competitive or collaborative
activities.

Providing and evaluating family interventions.

Evaluating usefulness of VR for social support for diabetes.

Utilizing motivational and teaching aspects of VR technology:

Embedding obesity and diabetes education and motivation in
existing VR games and systems.

Using VR to make behavior change more reinforcing and
participatory.

Monitoring behavior and providing individualized feedback,
including rewards and goal-setting.

Understanding the cognitive processes involved in learning and
applying health- and nutrition-related information.

Understanding the short-term vs. long-term motivational aspects
of VR, including attenuation of novelty, and how this influences effectiveness
and adherence.

Understanding determinants of decision processes involved with
acceptance, adoption, maintenance, and other aspects of good vs. poor adherence
to prevention and treatment regimens for obesity and diabetes.

Understanding the role of external visual cues in providing
reinforcement and motivation for exercise and increased daily physical activity
in sedentary patients with diabetes or obesity or in patients needing
cardiovascular exercise rehabilitation.

Enhanced displays and presentations of patient data for review by
health care providers.

Less threatening, more accessible behavioral coaching for
patients of various ages.

Social networking
capabilities of VR, including:

Social support through online communities for conditions such as
obesity (particularly morbid obesity), post-bariatric surgery status, diabetes
in children and adults, and extreme de-conditioning through inactivity.

Optimal characteristics for obestity and diabetes education as
embedded in existing VR games and systems.

Optimal characteristics for obesity and diabetes education as
embedded in existing VR games and systems.

Efficacy, reliability, and outcomes of game orientation (“serious
games”) to make behavior change more enjoyable and participatory.

Monitoring behavior and providing individualized feedback,
including rewards and goal-setting.

Components of cue responsiveness in diabetes and obesity
management skills under
environmental conditions of increasing complexity.
Understanding the short-term vs. long-term motivational and decision-making
aspects of VR, including attenuation of novelty, and how this influences
treatment effectiveness as well as acceptance, adoption, maintenance, and other
aspects of good vs.
poor adherence to prevention and treatment regimens.

Cognitive processes involved in learning and use of health- and
nutrition-related information, especially in obese or diabetic patients with
low print or numerical literacy skills.

Genetic and/or familial influences on perception of portion size
and other visual dimensions of food availability/appearance in relation to food
choices, caloric intake, and satiety.

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

In addition, pending availability of funds and
identification of suitable projects, TATRC may decide to co-fund
collaborative projects through offsets or administrative supplements when such
opportunities arise. Funds would be transferred through MIPR mechanisms
(equivalent to Interagency Agreement). TATRC has requested $250,000 for such
use.

Award Budget

Application budgets are not limited, but need to reflect
actual needs of the proposed project.

Award Project Period

Up to five years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Organizations) are
not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic groups
as well as individuals with disabilities are always encouraged to apply for NIH
support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission
applications may be submitted according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of Page
Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions
for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and
Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure
accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF 424 (R&R) Application Guide.

Types of research
and experimental approaches that are being sought to achieve the objectives of
this FOA

Applications responding to
this FOA should contain multidisciplinary research strategies drawing on
expertise in VR technologies, biomedical sciences (such as endocrinology,
nutrition, exercise physiology, cardiology), and
behavioral sciences. Projects should be clearly defined with regard to aspects
such as the research question to be answered, the technical approach, VR
platform, target population (by age, health condition, psychological status,
education or literacy level, etc), and research outcomes. Many projects can
usefully be conducted taking advantage of already existing tools, games, and
software, although applications also could seek to develop unique technologies.
Applications focusing only on electronic means of research data collection
(so-called “e-tools”), without VR components, will not be considered to fit the
objectives of this FOA.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact/priority score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center.
Applications will compete for available funds with all other recommended applications.
Following initial peer review, recommended applications will receive a second
level of review by the NHLBI National Advisory Council. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and Financial Status Report are required when an award is
relinquished when a recipient changes institutions or when an award is
terminated.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.